APPLICATION
ANDA209460
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-24
LATEST ACTION
2024-05-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ITRACONAZOLEPrescription
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2024-05-30Labeling · Supplement 7 · standardAP
2024-01-29Labeling · Supplement 5 · standardAP
2023-05-26Labeling · Supplement 4 · standardAP
2019-10-21Labeling · Supplement 2 · standardAP
2018-08-24UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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